AccessGUDID - DEVICE: Invacare® Comfort-Mate Extra Cushion (00841447111795)

GUDID

Device Identifier (DI) Information

Brand Name: Invacare® Comfort-Mate Extra Cushion
Version or Model: CMEX1416
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CMEX1416
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447111795
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: Comfort-Mate Extra Cushion 14 in x 16 in

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41622	Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IMP	CUSHION, WHEELCHAIR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e42f0aa4-1711-4f98-b5d5-2bc86b265286
Public Version Date: May 25, 2020
Public Version Number: 1
DI Record Publish Date: May 15, 2020